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United States · US · US:24979-126_8bf257be-d4c8-4694-b62b-f05124d378d0

CYCLOSPORINE

Orange BookUNIISPLATC S01XA18

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2497912618
    60 VIAL, SINGLE-USE in 1 CARTON (24979-126-18) / .4 mL in 1 VIAL, SINGLE-USE
  • ndc11
    2497912619
    30 VIAL, SINGLE-USE in 1 CARTON (24979-126-19) / .4 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A209064
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "83HN0GTJ6D",
    "rxcui": "3008",
    "inchikey": "PMATZTZNYRCHOR-CGLBZJNRSA-N",
    "display_name": "CYCLOSPORINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850": {
      "match": "brand_token",
      "title": "CYCLOSPORINE EMULSION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "24979-126_8bf257be-d4c8-4694-b62b-f05124d378d0",
  "productndc": "24979-126",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "209064",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Jan 21, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "CYCLOSPORINE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209064",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyclosporine",
  "start_marketing_date": "20260327",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code S01XA18.

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